Leaders in Microcontamination Monitoring
Founded in 1972, Particle Measuring Systems is the global leader in microcontamination monitoring systems and services. Our comprehensive line of instrumentation and software solutions enable process-driven companies to monitor their environmental quality and make fact-based decisions that improve process yield and meet regulatory requirements. Our technology portfolio includes particle counters, microbial monitors, molecular gas analyzers, and software for data management and automation.

Founded in 1972, Particle Measuring Systems is the global leader in microcontamination monitoring systems and services. Our comprehensive line of instrumentation and software solutions enable process-driven companies to monitor their environmental quality and make fact-based decisions that improve process yield and meet regulatory requirements. Our technology portfolio includes particle counters, microbial monitors, molecular gas analyzers, and software for data management and automation.
 
Integrated Solutions that Simplify Your Operations

Performing particle counting and microbial monitoring as separate activities increases the cost and complexity of Environmental Monitoring. We provide the products and services to integrate these activities to a common, validated system. This approach results in easier operation, cost reduction, and improved process understanding consistent with the Quality by Design (QbD) initiatives of the industry’s regulatory agencies.

The FacilityPro system rack resides in a technical or mezzanine area along with the vacuum pumps. Power, communications, and vacuum are run from FacilityPro to each sampling point in the cleanrooms as well as to each alarm tower. The SCADA server, optional redundant server, and client PCs can be located outside of the clean environment in a server room or other appropriate location, allowing for easy maintenance.

With the central vacuum approach, all components that may contaminate an environment are located safely outside the cleanroom. Sensors, alarm beacons and HMI clients are installed within the cleanroom to notify operators of any excursions and allow for operator control of the system. Portable sampling instruments can be used in the background area while data is downloaded into FacilityPro to ensure a single database holds all
environmental monitoring data.


 

Founded in 1972, Particle Measuring Systems is the global leader in microcontamination monitoring systems and services. Our comprehensive line of instrumentation and software solutions enable process-driven companies to monitor their environmental quality and make fact-based decisions that improve process yield and meet regulatory requirements. Our technology portfolio includes particle counters, microbial monitors, molecular gas analyzers, and software for data management and automation.
  Lasair® III Portable Particle Counter   Airnet® II Particle Sensor
 
The Lasair III Portable Particle Counter is the foundation of an environmental monitoring system. With its ability to perform room certifications and provide the ability for routine monitoring connected to an environmental monitoring system, the Lasair III is the instrument of choice for large and small systems alike. Available in three different flow rates (28.3, 50 or 100 LPM) to meet your specific monitoring or certification needs.

ISO 21501-4
The Lasair III Particle Counter meets the requirements of the latest ISO 21501-4 standard for particle counter calibrations. This calibration standard provides a consistent and repeatable calibration method to assure confidence in data results between instruments. Additionally, the Lasair III uses an internal Pulse Height Analyzer (PHA), removing additional calibration errors present in other portable counting devices.
  Airnet II sensors are an integral part of any Environmental Monitoring System. These remotely-mounted sensors operate unattended to provide accurate and reliable particle count data for any cleanroom.

ISO 21501-4 Compliant
The Lasair III Particle Counter meets the requirements of the latest ISO 21501-4 standard for particle counter calibrations. This calibration standard provides a consistent and repeatable calibration method to assure confidence in data results between instruments. Additionally, the Lasair III uses an internal Pulse Height Analyzer (PHA), removing additional calibration errors present in other portable counting devices.
  MiniCapt™ Portable Microbial Sampler   Air Trace® Slit-to-Agar Sampler
 
The MiniCapt uses the BioCapt technology for impaction of microbiological organisms onto an agar media. The BioCapt technology allows for high physical and biological collection efficiency in compliance with the ISO standard 14698-1.
The MiniCapt is available in 50 or 100 LPM flow rates and requires only 10 minutes for the collection of 1 m3. In standard configuration, the MiniCapt is used to sample all pharmaceutical grade environments.
  The Air Trace slit-to-agar sampler uses a single impaction slit above a rotating media plate to ensure the highest physical and microbiological collection efficiencies.



Programmable
Plate rotation speed can be programmed to cover 360° from 2 minutes to 4 hours. This allows the Air Trace to be used in process monitoring applications or for fast-response investigations.
  BioLaz™ Real-Time Microbial Monitor   BioLaz Validation to USP <1223> and EP 5.1.6
 
The move toward faster, leaner manufacturing practices brings a new paradigm to environmental monitoring — Rapid Microbial Monitoring (RMM). The BioLaz Real-Time Microbial Monitor provides real-time detection of biological organisms in controlled environments.
To validate the use of an alternative method for microbial monitoring, the BioLaz has been tested to the requirements of the USP <1223> and the EP 5.1.6.
The BioLaz samples air into the sensor; as the air
stream passes through the optics it is illuminated via a laser and the biological particles fluoresce. The fluorescing microorganisms are counted in one of two size channels.
  The BioLaz has been validated against the USP and EP requirements for alternative microbiological techniques and has successfully passed all requirements. It has also been verified against various high levels of microbiological organisms and single spore evaluations. The range of organisms tested against the USP is listed below. A full validation report is available.
• Bacillus subtilis (Bs), vegetative form.
• Bacillus globigii (Bg), spore form, washed.
• Bacillus globigii (Bg), spore form, unwashed.
• Bacillus thuringiensis (Bt), spore form, washed.
• Staphylococcus epidermidis, vegetative form.
  BioCapt™ Point-of-Use Microbial Sampler   False Positive Identification
 
The BioCapt Microbial Sampler is specifically designed for use within pharmaceutical-grade clean environments. Using remote vacuum reduces the footprint within controlled spaces, allowing for computer control of sampling programs.
Different connections to the BioCapt, including tri-clamp or hose-barb fittings, allow for multiple choices of installation into any process environment.
  To achieve the high sampling efficiencies demonstrated in the ISO testing, the BioCapt Sampler uses 20 individual slit openings to optimize the impaction velocity; impaction occurs within a very narrow surface area directly below a slit opening. This array-like impaction pattern on the surface of the agar media also allows for easy determination of false positives, which may not have been caused by the environment, but by either handling or post sampling errors.
 
APSS-2000 Liquid Particle Counter
The APSS-2000 syringe sampling system sizes and counts suspended particles in a wide range of liquids and exceeds all current USP, EP, and JP requirements.
Recipe functions allow the APSS-2000 to adapt easily to future regulatory changes.
The APSS-2000 system consists of an SLS-1000 syringe sampler, a LiQuilaz® E20P light obscuration spectrometer and SamplerSight – Pharma software. SamplerSight software meets 21 CFR Part 11 Electronic Records and Signatures requirements.
The system can be used in either front facing or side-on orientation, allowing for flexible positioning within the laminar flow cabinet.

  Validation   21 CFR Part 11 Security
 
A full validation manual accompanies every system and include test scripts to meet the IQ/OQ/PQ of the APSS-2000 sampler and software. Additionally a section of the manual gives SOP’s and EOP’s for the instrument integration into your laboratory. These are also available as electronic file formats if you want to integrate them into your processes.
  FacilityPro SCADA was designed with 21 CFR Part 11 requirements in mind.
All data is stored in a secure database and is not modifiable by any user.
Every user is given their own username and password. User authentication can be made against a local database or a corporate Microsoft Active Directory server.
 
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